Anti-Vascular Endothelial Growth Factor Drugs Compared With Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A Cost-Effectiveness Analysis.

OBJECTIVES: This study aimed to evaluate the cost-effectiveness of anti-vascular endothelial growth factor drugs (anti-VEGFs) compared with panretinal photocoagulation (PRP) for treating proliferative diabetic retinopathy (PDR) in the United Kingdom. METHODS: A discrete event simulation model was developed, informed by individual participant data meta-analysis. The model captures treatment effects on best corrected visual acuity in both eyes, and the occurrence of diabetic macular edema and vitreous hemorrhage. The model also estimates the value of undertaking further research to resolve decision uncertainty. RESULTS: Anti-VEGFs are unlikely to generate clinically meaningful benefits over PRP. The model predicted anti-VEGFs be more costly and similarly effective as PRP, generating 0.029 fewer quality-adjusted life-years at an additional cost of £3688, with a net health benefit of -0.214 at a £20 000 willingness-to-pay threshold. Scenario analysis results suggest that only under very select conditions may anti-VEGFs offer potential for cost-effective treatment of PDR. The consequences of loss to follow-up were an important driver of model outcomes. CONCLUSIONS: Anti-VEGFs are unlikely to be a cost-effective treatment for early PDR compared with PRP. Anti-VEGFs are generally associated with higher costs and similar health outcomes across various scenarios. Although anti-VEGFs were associated with lower diabetic macular edema rates, the number of cases avoided is insufficient to offset the additional treatment costs. Key uncertainties relate to the long-term comparative effectiveness of anti-VEGFs, particularly considering the real-world rates and consequences of treatment nonadherence. Further research on long-term visual acuity and rates of vision-threatening complications may be beneficial in resolving uncertainties.

Measures of socioeconomic advantage are not independent predictors of support for healthcare AI: subgroup analysis of a national Australian survey.

Objectives: Applications of artificial intelligence (AI) have the potential to improve aspects of healthcare. However, studies have shown that healthcare AI algorithms also have the potential to perpetuate existing inequities in healthcare, performing less effectively for marginalised populations. Studies on public attitudes towards AI outside of the healthcare field have tended to show higher levels of support for AI among socioeconomically advantaged groups that are less likely to be sufferers of algorithmic harms. We aimed to examine the sociodemographic predictors of support for scenarios related to healthcare AI.Methods: The Australian Values and Attitudes toward AI survey was conducted in March 2020 to assess Australians' attitudes towards AI in healthcare. An innovative weighting methodology involved weighting a non-probability web-based panel against results from a shorter omnibus survey distributed to a representative sample of Australians. We used multinomial logistic regression to examine the relationship between support for AI and a suite of sociodemographic variables in various healthcare scenarios.Results: Where support for AI was predicted by measures of socioeconomic advantage such as education, household income and Socio-Economic Indexes for Areas index, the same variables were not predictors of support for the healthcare AI scenarios presented. Variables associated with support for healthcare AI included being male, having computer science or programming experience and being aged between 18 and 34 years. Other Australian studies suggest that these groups may have a higher level of perceived familiarity with AI.Conclusion: Our findings suggest that while support for AI in general is predicted by indicators of social advantage, these same indicators do not predict support for healthcare AI.

Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT.

BACKGROUND: The National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm on optical coherence tomography. The DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial compared standard threshold macular laser with subthreshold micropulse laser to treat diabetic macular oedema suitable for macular laser. OBJECTIVES: Determining the clinical effectiveness, safety and cost-effectiveness of subthreshold micropulse laser compared with standard threshold macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm. DESIGN: A pragmatic, multicentre, allocation-concealed, double-masked, randomised, non-inferiority, clinical trial. SETTING: Hospital eye services in the UK. PARTICIPANTS: Adults with diabetes and centre-involving diabetic macular oedema with a central retinal subfield thickness of < 400 µm, and a visual acuity of > 24 Early Treatment Diabetic Retinopathy Study letters (Snellen equivalent > 20/320) in one/both eyes. INTERVENTIONS: Participants were randomised 1 : 1 to receive 577 nm subthreshold micropulse laser or standard threshold macular laser (e.g. argon laser, frequency-doubled neodymium-doped yttrium aluminium garnet 532 nm laser); laser treatments could be repeated as needed. Rescue therapy with intravitreal anti-vascular endothelial growth factor therapies or steroids was allowed if a loss of ≥ 10 Early Treatment Diabetic Retinopathy Study letters between visits occurred and/or central retinal subfield thickness increased to > 400 µm. MAIN OUTCOME MEASURES: The primary outcome was the mean change in best-corrected visual acuity in the study eye at 24 months (non-inferiority margin 5 Early Treatment Diabetic Retinopathy Study letters). Secondary outcomes included the mean change from baseline to 24 months in the following: binocular best-corrected visual acuity; central retinal subfield thickness; the mean deviation of the Humphrey 10-2 visual field in the study eye; the percentage of people meeting driving standards; and the EuroQol-5 Dimensions, five-level version, National Eye Institute Visual Function Questionnaire - 25 and Vision and Quality of Life Index scores. Other secondary outcomes were the cost per quality-adjusted life-years gained, adverse effects, number of laser treatments and additional rescue treatments. RESULTS: The DIAMONDS trial recruited fully (n = 266); 87% of participants in the subthreshold micropulse laser group and 86% of participants in the standard threshold macular laser group had primary outcome data. Groups were balanced regarding baseline characteristics. Mean best-corrected visual acuity change in the study eye from baseline to month 24 was -2.43 letters (standard deviation 8.20 letters) in the subthreshold micropulse laser group and -0.45 letters (standard deviation 6.72 letters) in the standard threshold macular laser group. Subthreshold micropulse laser was deemed to be not only non-inferior but also equivalent to standard threshold macular laser as the 95% confidence interval (-3.9 to -0.04 letters) lay wholly within both the upper and lower margins of the permitted maximum difference (5 Early Treatment Diabetic Retinopathy Study letters). There was no statistically significant difference between groups in any of the secondary outcomes investigated with the exception of the number of laser treatments performed, which was slightly higher in the subthreshold micropulse laser group (mean difference 0.48, 95% confidence interval 0.18 to 0.79; p = 0.002). Base-case analysis indicated no significant difference in the cost per quality-adjusted life-years between groups. FUTURE WORK: A trial in people with ≥ 400 µm diabetic macular oedema comparing anti-vascular endothelial growth factor therapy alone with anti-vascular endothelial growth factor therapy and macular laser applied at the time when central retinal subfield thickness has decreased to < 400 µm following anti-vascular endothelial growth factor injections would be of value because it could reduce the number of injections and, subsequently, costs and risks and inconvenience to patients. LIMITATIONS: The majority of participants enrolled had poorly controlled diabetes. CONCLUSIONS: Subthreshold micropulse laser was equivalent to standard threshold macular laser but required a slightly higher number of laser treatments. TRIAL REGISTRATION: This trial is registered as EudraCT 2015-001940-12, ISRCTN17742985 and NCT03690050. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 50. See the NIHR Journals Library website for further project information.

The retina is a layer at the back of the eye. Its centre is called the macula and is responsible for central vision. Some people with diabetes develop diabetic macular oedema. In diabetic macular oedema fluid leaks from retinal blood vessels and builds up at the macula, resulting in sight loss. Diabetic macular oedema can be mild or severe; this can be determined measuring the thickness of the macula, which is measured in micrometres (µm). One micrometre is one thousandth of a millimetre. In mild diabetic macular oedema, the thickness of the macula increases, but is less than 400 µm. Patients with mild diabetic macular oedema can be treated with a laser and there are two laser types. The standard threshold macular laser has been available for many years. It clears the diabetic macular oedema but produces a 'burn' in the retina. The subthreshold micropulse laser is newer. It does not produce a burn but also clears the diabetic macular oedema. The lack of a burn, however, has led to doubts about whether or not this laser works as well as the standard threshold macular laser because 'no burn' was taken to mean 'less benefit'. These doubts led to our establishing the DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial, which compared these two lasers for people with mild diabetic macular oedema. A total of 266 people suitable for either laser joined the study at 16 NHS hospitals across the UK; 133 received standard threshold macular laser and 133 received subthreshold micropulse laser. The choice of laser was determined by chance. The DIAMONDS trial found that the subthreshold micropulse laser was as good as the standard threshold macular laser (i.e. 'clinically equivalent') in terms of improving people's vision, reducing macula thickness, allowing people to meet driving standards and maintaining their quality of life, both in general terms and for vision in particular. There was a small increase (less than one session on average per person) in the number of laser treatment sessions needed with subthreshold micropulse laser. The costs of both laser treatments were about the same.

The Adoption of Artificial Intelligence in Health Care and Social Services in Australia: Findings From a Methodologically Innovative National Survey of Values and Attitudes (the AVA-AI Study).

BACKGROUND: Artificial intelligence (AI) for use in health care and social services is rapidly developing, but this has significant ethical, legal, and social implications. Theoretical and conceptual research in AI ethics needs to be complemented with empirical research to understand the values and judgments of members of the public, who will be the ultimate recipients of AI-enabled services. OBJECTIVE: The aim of the Australian Values and Attitudes on AI (AVA-AI) study was to assess and compare Australians' general and particular judgments regarding the use of AI, compare Australians' judgments regarding different health care and social service applications of AI, and determine the attributes of health care and social service AI systems that Australians consider most important. METHODS: We conducted a survey of the Australian population using an innovative sampling and weighting methodology involving 2 sample components: one from an omnibus survey using a sample selected using scientific probability sampling methods and one from a nonprobability-sampled web-based panel. The web-based panel sample was calibrated to the omnibus survey sample using behavioral, lifestyle, and sociodemographic variables. Univariate and bivariate analyses were performed. RESULTS: We included weighted responses from 1950 Australians in the web-based panel along with a further 2498 responses from the omnibus survey for a subset of questions. Both weighted samples were sociodemographically well spread. An estimated 60% of Australians support the development of AI in general but, in specific health care scenarios, this diminishes to between 27% and 43% and, for social service scenarios, between 31% and 39%. Although all ethical and social dimensions of AI presented were rated as important, accuracy was consistently the most important and reducing costs the least important. Speed was also consistently lower in importance. In total, 4 in 5 Australians valued continued human contact and discretion in service provision more than any speed, accuracy, or convenience that AI systems might provide. CONCLUSIONS: The ethical and social dimensions of AI systems matter to Australians. Most think AI systems should augment rather than replace humans in the provision of both health care and social services. Although expressing broad support for AI, people made finely tuned judgments about the acceptability of particular AI applications with different potential benefits and downsides. Further qualitative research is needed to understand the reasons underpinning these judgments. The participation of ethicists, social scientists, and the public can help guide AI development and implementation, particularly in sensitive and value-laden domains such as health care and social services.

Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study.

BACKGROUND: Owing to the increasing prevalence of diabetes, the workload related to diabetic macular oedema and proliferative diabetic retinopathy is rising, making it difficult for hospital eye services to meet demands. OBJECTIVE: The objective was to evaluate the diagnostic performance, cost-effectiveness and acceptability of a new pathway using multimodal imaging interpreted by ophthalmic graders to detect reactivation of diabetic macular oedema/proliferative diabetic retinopathy in previously treated patients. DESIGN: This was a prospective, case-referent, cross-sectional diagnostic study. SETTING: The setting was ophthalmic clinics in 13 NHS hospitals. PARTICIPANTS: Adults with type 1 or type 2 diabetes with previously successfully treated diabetic macular oedema/proliferative diabetic retinopathy in one/both eyes in whom, at the time of enrolment, diabetic macular oedema/proliferative diabetic retinopathy could be active or inactive. METHODS: For the ophthalmic grader pathway, review of the spectral domain optical coherence tomography scans to detect diabetic macular oedema, and seven-field Early Treatment Diabetic Retinopathy Study/ultra-wide field fundus images to detect proliferative diabetic retinopathy, by trained ophthalmic graders. For the current standard care pathway (reference standard), ophthalmologists examined patients face to face by slit-lamp biomicroscopy for proliferative diabetic retinopathy and, in addition, spectral domain optical coherence tomography imaging for diabetic macular oedema. OUTCOME MEASURES: The primary outcome measure was sensitivity of the ophthalmic grader pathway to detect active diabetic macular oedema/proliferative diabetic retinopathy. The secondary outcomes were specificity, agreement between pathways, cost-consequences, acceptability and the proportion of patients requiring subsequent ophthalmologist assessment, unable to undergo imaging and with inadequate quality images/indeterminate findings. It was assumed for the main analysis that all patients in whom graders diagnosed active disease or were 'unsure' or images were 'ungradable' required examination by an ophthalmologist. RESULTS: Eligible participants with active and inactive diabetic macular oedema (152 and 120 participants, respectively) and active and inactive proliferative diabetic retinopathy (111 and 170 participants, respectively) were recruited. Under the main analysis, graders had a sensitivity of 97% (142/147) (95% confidence interval 92% to 99%) and specificity of 31% (35/113) (95% confidence interval 23% to 40%) to detect diabetic macular oedema. For proliferative diabetic retinopathy, graders had a similar sensitivity and specificity using seven-field Early Treatment Diabetic Retinopathy Study [sensitivity 85% (87/102), 95% confidence interval 77% to 91%; specificity 48% (77/160), 95% confidence interval 41% to 56%] or ultra-wide field imaging [sensitivity 83% (87/105), 95% confidence interval 75% to 89%; specificity 54% (86/160), 95% confidence interval 46% to 61%]. Participants attending focus groups expressed preference for face-to-face evaluations by ophthalmologists. In the ophthalmologists' absence, patients voiced the need for immediate feedback following grader's assessments, maintaining periodic evaluations by ophthalmologists. Graders and ophthalmologists were supportive of the new pathway. When compared with the reference standard (current standard pathway), the new grader pathway could save £1390 per 100 patients in the review of people with diabetic macular oedema and, depending on the imaging modality used, between £461 and £1189 per 100 patients in the review of people with proliferative diabetic retinopathy. CONCLUSIONS: For people with diabetic macular oedema, the ophthalmic grader pathway appears safe and cost saving. The sensitivity of the new pathway to detect active proliferative diabetic retinopathy was lower, but may still be considered acceptable for patients with proliferative diabetic retinopathy previously treated with laser. Suggestions from focus group discussions should be taken into consideration if the new pathway is introduced to ensure its acceptability to users. LIMITATIONS: Lack of fundus fluorescein angiography to confirm diagnosis of active proliferative diabetic retinopathy. FUTURE WORK: Could refinement of the new pathway increase its sensitivity to detect proliferative diabetic retinopathy? Could artificial intelligence be used for automated reading of images in this previously treated population? TRIAL REGISTRATION: Current Controlled Trials ISRCTN10856638 and ClinicalTrials.gov NCT03490318. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology AssessmentVol. 25, No. 32. See the NIHR Journals Library website for further project information.

More and more people are developing diabetes. Diabetic macular oedema and proliferative diabetic retinopathy are complications of diabetes, which could cause blindness. Thus, people with diabetic macular oedema and proliferative diabetic retinopathy need to be treated in a timely manner and reviewed in clinic for life. The population in the world is ageing. As a result, there are more people with eye diseases. There are also more treatments now for people with eye diseases. The workload in hospitals is increasing, making it difficult for the NHS to cope with the demand. There are not enough ophthalmologists (eye doctors) to look after patients. Delayed appointments and treatment mean that patients may lose sight. The goal of EMERALD (Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy) was to see if patients with treated and stable diabetic macular oedema or proliferative diabetic retinopathy could be followed by 'ophthalmic graders', who are not doctors but are trained to diagnose diabetic macular oedema and proliferative diabetic retinopathy. In EMERALD, trained ophthalmic graders examined photographs of the back of the eye of people with diabetic macular oedema and proliferative diabetic retinopathy. They checked if diabetic macular oedema and proliferative diabetic retinopathy remain inactive. If so, patients could continue follow-up with the ophthalmic graders. If diabetic macular oedema or proliferative diabetic retinopathy were active, graders would immediately refer patients to ophthalmologists. EMERALD found that graders were excellent at detecting diabetic macular oedema, and this could give ophthalmologists time to see other patients. Graders were not quite as good at detecting active proliferative diabetic retinopathy. However, considering that patients had already had treatment, this may still be safe. Patients participating in focus group discussions mentioned that they would prefer to see ophthalmologists, so they could ask questions about their eye condition. If this was not possible, they would like to have immediate results from graders and still see the ophthalmologist from time to time.

Evaluation of a New Model of Care for People with Complications of Diabetic Retinopathy: The EMERALD Study.

PURPOSE: The increasing diabetes prevalence and advent of new treatments for its major visual-threatening complications (diabetic macular edema [DME] and proliferative diabetic retinopathy [PDR]), which require frequent life-long follow-up, have increased hospital demands markedly. Subsequent delays in patient's evaluation and treatment are causing sight loss. Strategies to increase capacity are needed urgently. The retinopathy (EMERALD) study tested diagnostic accuracy, acceptability, and costs of a new health care pathway for people with previously treated DME or PDR. DESIGN: Prospective, multicenter, case-referent, cross-sectional, diagnostic accuracy study undertaken in 13 hospitals in the United Kingdom. PARTICIPANTS: Adults with type 1 or 2 diabetes previously successfully treated DME or PDR who, at the time of enrollment, had active or inactive disease. METHODS: A new health care pathway entailing multimodal imaging (spectral-domain OCT for DME, and 7-field Early Treatment Diabetic Retinopathy Study [ETDRS] and ultra-widefield [UWF] fundus images for PDR) interpreted by trained nonmedical staff (ophthalmic graders) to detect reactivation of disease was compared with the current standard care (face-to-face examination by ophthalmologists). MAIN OUTCOME MEASURES: Primary outcome: sensitivity of the new pathway. SECONDARY OUTCOMES: specificity; agreement between pathways; costs; acceptability; proportions requiring subsequent ophthalmologist assessment, unable to undergo imaging, and with inadequate images or indeterminate findings. RESULTS: The new pathway showed sensitivity of 97% (95% confidence interval [CI], 92%-99%) and specificity of 31% (95% CI, 23%-40%) to detect DME. For PDR, sensitivity and specificity using 7-field ETDRS images (85% [95% CI, 77%-91%] and 48% [95% CI, 41%-56%], respectively) or UWF images (83% [95% CI, 75%-89%] and 54% [95% CI, 46%-61%], respectively) were comparable. For detection of high-risk PDR, sensitivity and specificity were higher when using UWF images (87% [95% CI, 78%-93%] and 49% [95% CI, 42%-56%], respectively, for UWF versus 80% [95% CI, 69-88%] and 40% [95% CI, 34%-47%], respectively, for 7-field ETDRS images). Participants preferred ophthalmologists' assessments; in their absence, they preferred immediate feedback by graders, maintaining periodic ophthalmologist evaluations. When compared with the current standard of care, the new pathway could save £1390 per 100 DME visits and between £461 and £1189 per 100 PDR visits. CONCLUSIONS: The new pathway has acceptable sensitivity and would release resources. Users' suggestions should guide implementation.

Assessment of the Vitreomacular Interface Using High-Resolution OCT in a Population-Based Cohort Study of Older Adults.

PURPOSE: To describe the prevalence of vitreomacular interface (VMI) features and their associated risk factors in the Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) Study. DESIGN: Cross-sectional population-based study. PARTICIPANTS: Noninstitutionalized Northern Irish adults 40 years of age or older. METHODS: Using geographic stratification, a representative sample of people in Northern Ireland was invited to participate in the NICOLA Study. SD OCT images of participants were graded for vitreomacular traction (VMT), macular hole (MH), and epiretinal membrane (ERM) according to the International Vitreomacular Traction Study Group. A subsample was graded in more detail to estimate the prevalence of VMA and VMA area detailing size and location of VMA. Descriptive analysis and risk factors for each VMI feature were determined using generalized estimating equations. Results were standardized to the Northern Ireland population census (2011). MAIN OUTCOME MEASURES: Cohort profile, standardized prevalence, and risk factor associations of each VMI feature. RESULTS: Three thousand three hundred fifty-one NICOLA participants had gradable SD OCT images available for at least 1 eye. The prevalence of VMT was 0.5% (CI, 0.31%-0.70%), that for MH was 0.3% (CI, 0.23%-0.52%), and that for ERM was 7.6% (CI, 7.0%-8.3%). A detailed VMA analysis was performed on a subsample consisting of the first 1481 participants. The prevalence of VMA was 22.6% (CI, 21.1-24.2), and VMA area ranged from 0.25 to 42.7 mm2 (mean, 12.53 mm2; standard deviation, 6.90 mm2). In multivariate analyses, increased age was associated with an increased odds ratio (OR) of VMT, MH, and ERM. VMA area was positively associated with younger age and normal blood pressure. ERM and MH were present more often in more myopic eyes, associated with an increase in levels of high-density lipoprotein (HDL) cholesterol and triglycerides. CONCLUSIONS: The epidemiologic characteristics of VMI features indicated that VMI interactions throughout life are age dependent. Vitreous separation reduced to a greater extent in the horizontal meridians compared with the vertical, differing from previous studies. Future longitudinal studies of the evolution of these VMI changes over time would be of great interest.

Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD).

INTRODUCTION: Diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR) are the major causes of sight loss in people with diabetes. Due to the increased prevalence of diabetes, the workload related to these complications is increasing making it difficult for Hospital Eye Services (HSE) to meet demands. METHODS AND ANALYSIS: Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD) is a prospective, case-referent, cross-sectional diagnostic study. It aims at determining the diagnostic performance, cost-effectiveness and acceptability of a new form of surveillance for people with stable DMO and/or PDR, which entails multimodal imaging and image review by an ophthalmic grader, using the current standard of care (evaluation of patients in clinic by an ophthalmologist) as the reference standard. If safe, cost-effective and acceptable, this pathway could help HES by freeing ophthalmologist time. The primary outcome of EMERALD is sensitivity of the new surveillance pathway in detecting active DMO/PDR. Secondary outcomes include specificity, agreement between new and the standard care pathway, positive and negative likelihood ratios, cost-effectiveness, acceptability, proportion of patients requiring subsequent full clinical assessment, unable to undergo imaging, with inadequate quality images or indeterminate findings. ETHICS AND DISSEMINATION: Ethical approval was obtained for this study from the Office for Research Ethics Committees Northern Ireland (reference 17/NI/0124). Study results will be published as a Health Technology Assessment monograph, in peer-reviewed national and international journals and presented at national/international conferences and to patient groups. TRIAL REGISTRATION NUMBER: NCT03490318 and ISRCTN:10856638.

Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial.

BACKGROUND: In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) < 400 µm, as per National Institute for Health and Care Excellence guidelines. It remains unclear whether subthreshold micropulse laser is superior and should replace standard threshold laser for the treatment of eligible patients. METHODS: DIAMONDS is a pragmatic, multicentre, allocation-concealed, randomised, equivalence, double-masked clinical trial that aims to determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser compared with standard threshold laser, for the treatment of diabetic macular oedema with CST < 400 µm. The primary outcome is the mean change in best-corrected visual acuity in the study eye from baseline to month 24 post treatment. Secondary outcomes (at 24 months) include change in binocular best corrected visual acuity; CST; mean deviation of the Humphrey 10-2 visual field; change in percentage of people meeting driving standards; European Quality of Life-5 Dimensions, National Eye Institute Visual Functioning Questionnaire-25 and VisQoL scores; incremental cost per quality-adjusted life year gained; side effects; number of laser treatments and use of additional therapies. The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials. The difference between lasers for change in best-corrected visual acuity (using 95% CI) will be compared to the permitted maximum difference of five Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Linear and logistic regression models will be used to compare outcomes between treatment groups. A Markov-model-based cost-utility analysis will extend beyond the trial period to estimate longer-term cost-effectiveness. DISCUSSION: This trial will determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser, when compared with standard threshold laser, for the treatment of diabetic macular oedema, the main cause of sight loss in people with diabetes mellitus. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN17742985 . Registered on 19 May 2017 (retrospectively registered).

The Case Mix of Patients Presenting with Full-Thickness Macular Holes and Progression before Surgery: Implications for Optimum Management.

AIMS: Analysis of pre-operative spectral domain optical coherence tomography (SD-OCT) characteristics of full-thickness macular holes (FTMH) and effect on optimum management. METHODS: We retrospectively reviewed SD-OCT characteristics of a consecutive cohort of patients waitlisted for FTMH surgery and categorized them by current evidence-based treatments. RESULTS: Out of the 106 holes analysed, 36 were small, 40 medium and 30 large. Initially, 33 holes had vitreomacular adhesion (VMA). 41 holes were analysed for change in characteristics with a median duration of 8 weeks between the scans. The number of small or medium holes decreased from 20 to 6 and that of large holes doubled. The number of holes with VMA halved. Smaller hole size (p = 0.014) and being phakic (p = 0.048) were associated with a larger increase in size. The strongest predictor of hole progression into a different surgical management category was the presence of VMA. CONCLUSION: FTMH characteristics can change significantly pre-operatively and affect optimal treatment choice.

United Kingdom: Health System Review.

This analysis of the United Kingdom health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. It provides an overview of how the national health services operate in the four nations that make up the United Kingdom, as responsibility for organizing health financing and services was devolved from 1997. With devolution, the health systems in the United Kingdom have diverged in the details of how services are organized and paid for, but all have maintained national health services which provide universal access to a comprehensive package of services that are mostly free at the point of use. These health services are predominantly financed from general taxation and 83.5% of total health expenditure in the United Kingdom came from public sources in 2013. Life expectancy has increased steadily across the United Kingdom, but health inequalities have proved stubbornly resistant to improvement, and the gap between the most deprived and the most privileged continues to widen, rather than close. The United Kingdom faces challenges going forward, including how to cope with the needs of an ageing population, how to manage populations with poor health behaviours and associated chronic conditions, how to meet patient expectations of access to the latest available medicines and technologies, and how to adapt a system that has limited resources to expand its workforce and infrastructural capacity so it can rise to these challenges.

United Kingdom: health system review

This analysis of the United Kingdom health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. It provides an overview of how the national health services operate in the four nations that make up the United Kingdom, as responsibility for organizing health financing and services was devolved from 1997. With devolution, the health systems in the United Kingdom have diverged in the details of how services are organized and paid for, but all have maintained national health services which provide universal access to a comprehensive package of services that are mostly free at the point of use. These health services are predominantly financed from general taxation and 83.5% of total health expenditure in the United Kingdom came from public sources in 2013. Life expectancy has increased steadily across the United Kingdom, but health inequalities have proved stubbornly resistant to improvement, and the gap between the most deprived and the most privileged continues to widen, rather than close. The United Kingdom faces challenges going forward, including how to cope with the needs of an ageing population, how to manage populations with poor health behaviours and associated chronic conditions, how to meet patient expectations of access to the latest available medicines and technologies, and how to adapt a system that has limited resources to expand its workforce and infrastructural capacity so it can rise to these challenges.

Alcohol and smoking consumption behaviours in older Australian adults: prevalence, period and socio-demographic differentials in the DYNOPTA sample.

PURPOSE: Alcohol consumption and tobacco use are key risk factors for chronic disease and health burden across the adult lifespan. We estimate the prevalence of alcohol consumption and smoking by age and time period in adults from mid to old age. METHODS: Participants (n = 50,652) were drawn from the Dynamic Analyses to Optimise Ageing (DYNOPTA) project and were compared with Australian National Health Survey data. Alcohol and smoking consumption DYNOPTA data were weighted to the estimated resident population of the sampling frame for each contributing study according to age and sex distributions within major statistical regions. RESULTS: Comparisons in the rates of smoking and alcohol consumption between DYNOPTA and other national surveys were comparable. Males were more likely to be (RRR = 2.12) or have been smokers (RRR = 2.97), whilst females were more likely to be non-drinkers (RRR = 2.52). Period effects were also identified; higher prevalence rates in consumption of alcohol (RRR = 3.21) and smoking (RRR = 1.67) for those contributing studies from the early 1990's, in comparison with those studies from the latter half of the decade, were reported. CONCLUSIONS: Over a decade, prevalence rates for high-risk consumption of alcohol and current smoking behaviour declined and suggest the possible impact of government health policy, with targeted-health policies, that included bans on public smoking, and a toughening of legislation against alcohol-related crime.

Inclusion of mobile phone numbers into an ongoing population health survey in New South Wales, Australia: design, methods, call outcomes, costs and sample representativeness.

BACKGROUND: In Australia telephone surveys have been the method of choice for ongoing jurisdictional population health surveys. Although it was estimated in 2011 that nearly 20% of the Australian population were mobile-only phone users, the inclusion of mobile phone numbers into these existing landline population health surveys has not occurred. This paper describes the methods used for the inclusion of mobile phone numbers into an existing ongoing landline random digit dialling (RDD) health survey in an Australian state, the New South Wales Population Health Survey (NSWPHS). This paper also compares the call outcomes, costs and the representativeness of the resultant sample to that of the previous landline sample. METHODS: After examining several mobile phone pilot studies conducted in Australia and possible sample designs (screening dual-frame and overlapping dual-frame), mobile phone numbers were included into the NSWPHS using an overlapping dual-frame design. Data collection was consistent, where possible, with the previous years' landline RDD phone surveys and between frames. Survey operational data for the frames were compared and combined. Demographic information from the interview data for mobile-only phone users, both, and total were compared to the landline frame using χ2 tests. Demographic information for each frame, landline and the mobile-only (equivalent to a screening dual frame design), and the frames combined (with appropriate overlap adjustment) were compared to the NSW demographic profile from the 2011 census using χ2 tests. RESULTS: In the first quarter of 2012, 3395 interviews were completed with 2171 respondents (63.9%) from the landline frame (17.6% landline only) and 1224 (36.1%) from the mobile frame (25.8% mobile only). Overall combined response, contact and cooperation rates were 33.1%, 65.1% and 72.2% respectively. As expected from previous research, the demographic profile of the mobile-only phone respondents differed most (more that were young, males, Aboriginal and Torres Strait Islanders, overseas born and single) compared to the landline frame responders. The profile of respondents from the two frames combined, with overlap adjustment, was most similar to the latest New South Wales (NSW) population profile. CONCLUSIONS: The inclusion of the mobile phone numbers, through an overlapping dual-frame design, did not impact negatively on response rates or data collection, and although costing more the design was still cost-effective because of the additional interviews that were conducted with young people, Aboriginal and Torres Strait Islanders and people who were born overseas resulting in a more representative overall sample.

United Kingdom (Scotland): Health system review.

Over the last decade, Scotland's health system has increasingly diverged from the health system in England. Scotland has pursued an approach stressing integration and partnership among all parts of its NHS as opposed to an English approach in part driven by market forces. Comparatively fewer organizational and structural changes, in addition to consistent policy objectives, have provided a strong launching pad for achieving improvement. Substantial increases in funding have led to significant growth in the clinical workforce and numerous performance targets have been set to improve population health, the quality and outcomes of health care, and the efficiency of the health system. As a result, Scotland has made well-documented progress in terms of population health and the quality and effectiveness of care. However, a number of challenges remain. More progress is needed to close the gap in health status between Scotland and other developed countries, and to address persistent inequalities in health within Scotland. As in many other countries, increased fiscal pressures may make it difficult to maintain current levels of health care quantity and quality in future.

United Kingdom (Scotland): health system review

Over the last decade, Scotland’s health system has increasingly diverged from the health system in England. Scotland has pursued an approach stressing integration and partnership among all parts of its NHS as opposed to an English approach in part driven by market forces. Comparatively fewer organizational and structural changes, in addition to consistent policy objectives, have provided a strong launching pad for achieving improvement. Substantial increases in funding have led to significant growth in the clinical workforce and numerous performance targets have been set to improve population health, the quality and outcomes of health care, and the efficiency of the health system. As a result, Scotland has made well documented progress in terms of population health and the quality and effectiveness of care. However, a number of challenges remain. More progress is needed to close the gap in health status between Scotland and other developed countries, and to address persistent inequalities in health within Scotland. As in many other countries, increased fiscal pressures may make it difficult to maintain current levels of health care quantity and quality in future.

Assessment of stereoscopic optic disc images using an autostereoscopic screen - experimental study.

BACKGROUND: Stereoscopic assessment of the optic disc morphology is an important part of the care of patients with glaucoma. The aim of this study was to assess stereoviewing of stereoscopic optic disc images using an example of the new technology of autostereoscopic screens compared to the liquid shutter goggles. METHODS: Independent assessment of glaucomatous disc characteristics and measurement of optic disc and cup parameters whilst using either an autostereoscopic screen or liquid crystal shutter goggles synchronized with a view switching display. The main outcome measures were inter-modality agreements between the two used modalities as evaluated by the weighted kappa test and Bland Altman plots. RESULTS: Inter-modality agreement for measuring optic disc parameters was good [Average kappa coefficient for vertical Cup/Disc ratio was 0.78 (95% CI 0.62-0.91) and 0.81 (95% CI 0.6-0.92) for observer 1 and 2 respectively]. Agreement between modalities for assessing optic disc characteristics for glaucoma on a five-point scale was very good with a kappa value of 0.97. CONCLUSION: This study compared two different methods of stereo viewing. The results of assessment of the different optic disc and cup parameters were comparable using an example of the newly developing autostereoscopic display technologies as compared to the shutter goggles system used. The Inter-modality agreement was high. This new technology carries potential clinical usability benefits in different areas of ophthalmic practice.